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FDA rejects de novo application for Aussie digital health company Resapp’s respiratory diagnostic

March 19, 2020
By Tamra Sami
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
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Regulatory front for March 19, 2020

March 19, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Intercept.
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FDA, drug developers grapple with COVID-19's impact on trials

March 18, 2020
By Michael Fitzhugh
With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic.
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Regulatory front for March 18, 2020

March 18, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Australian flag marking country on globe

TGA refines proposals to reclassify six groups of medical devices based on industry comments

March 18, 2020
By Tamra Sami
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Aug. 25, 2020, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
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China approves first homegrown COVID-19 vaccine to enter clinical trials

March 18, 2020
By Elise Mak
BEIJING – One day after the U.S. began the first human trial of an mRNA vaccine candidate for COVID-19 on March 16, China said Tuesday evening that it had approved the first clinical trial of a vaccine candidate developed by domestic researchers.
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Regulatory front for March 18, 2020

March 18, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Astrazeneca, Boehringer Ingelheim, Janssen, Lilly, Merck.
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Earth infected with pandemic

Officially a pandemic, but COVID-19 fight far from over, says WHO director general

March 17, 2020
By Nuala Moran
LONDON – The World Health Organization (WHO) has officially declared COVID-19 a pandemic, but is pushing back strongly against countries giving up on stringent control measures.
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Architectural pillars

Regulatory front for March 17, 2020

March 17, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: U.S. Trade Representative, World Trade Organization.
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South Korean shield, coronavirus

South Korea approves first four COVID-19 test kits under urgent-use license

March 17, 2020
By Gina Lee
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.
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